guanfacine hydrochloride

Generic: guanfacine hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine hydrochloride
Generic Name guanfacine hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine 2 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3516
Product ID 70518-3516_3ab0077f-1e34-be44-e063-6294a90a4e6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214689
Listing Expiration 2026-12-31
Marketing Start 2022-09-13

Pharmacologic Class

Established (EPC)
central alpha-2 adrenergic agonist [epc]
Mechanism of Action
adrenergic alpha2-agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183516
Hyphenated Format 70518-3516

Supplemental Identifiers

RxCUI
197746
UNII
30OMY4G3MK
NUI
N0000009918 N0000175554

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name guanfacine hydrochloride (source: ndc)
Generic Name guanfacine hydrochloride (source: ndc)
Application Number ANDA214689 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3516-0)
source: ndc

Packages (1)

70518-3516-0 30 TABLET in 1 BLISTER PACK (70518-3516-0)

Ingredients (1)

guanfacine (2 mg/1)

Linked Drug Pages (1)

Guanfacine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ab0077f-1e34-be44-e063-6294a90a4e6c", "openfda": {"nui": ["N0000009918", "N0000175554"], "unii": ["30OMY4G3MK"], "rxcui": ["197746"], "spl_set_id": ["1b1063ba-fee3-4540-9139-db4b915f82e2"], "pharm_class_epc": ["Central alpha-2 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic alpha2-Agonists [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3516-0)", "package_ndc": "70518-3516-0", "marketing_start_date": "20220913"}], "brand_name": "Guanfacine Hydrochloride", "product_id": "70518-3516_3ab0077f-1e34-be44-e063-6294a90a4e6c", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70518-3516", "generic_name": "Guanfacine Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine Hydrochloride", "active_ingredients": [{"name": "GUANFACINE", "strength": "2 mg/1"}], "application_number": "ANDA214689", "marketing_category": "ANDA", "marketing_start_date": "20220913", "listing_expiration_date": "20261231"}